NCT00104338终止2 期
A Phase 2, Proof of Concept, Randomized, Open-label, Two-arm, Parallel Group, Multi-center Study to Assess the Efficacy and Safety of FK778 Compared With Standard Care in Renal Transplant Recipients With Untreated BK Nephropathy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 21
- 主要终点
- Change from baseline in urine BK viral load
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy.
详细描述
The purpose of this study is to assess the efficacy and safety of FK778 compared with standard care in renal transplant recipients with newly diagnosed and untreated BK nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant recipient with newly diagnosed BK nephropathy.
排除标准
- •Previous treatment for BK nephropathy
- •Organ transplant other than kidney
- •Uncontrolled concomitant infection other than BK nephropathy
结局指标
主要结局
Change from baseline in urine BK viral load
次要结局
- Change from baseline in plasma BK viral load
- Change from baseline in renal function as measured by serum creatinine (SCr) and creatinine clearance (CrCl) at month 6 or at the end of therapy, whichever is earlier
- Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier
研究者
研究点 (21)
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